Recall Z-0076-2022— Datascope Corp.

Name: FDA recall Z-0076-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-08

Class II · Ongoing

Class II FDA medical device recall by Datascope Corp., initiated 2021-09-08. It names one FDA 510(k) clearance: K181122. Product: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85. Reason: The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference..

Recalling firm: Datascope Corp.
Classification: Class II
Status: Ongoing
Initiated: 2021-09-08
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K181122 — CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp.·cleared 2018-05-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85

Reason for recall

The Helium Indicator on the Cardiosave display may over represent the amount of helium in unit in the presence of Electromagnetic Interference.

Data sourced from openFDA. This site is unofficial and independent of the FDA.